Locking Plates for Extremity Fractures A Technology Overview EVIDENCE TABLES
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- Sibyl Harrell
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1 Locking Plates for Extremity Fractures A Technology Overview EVIDENCE TABLES Adopted by the American Academy of Orthopaedic Surgeons Board of Directors December 6, This document is a supplement to the Technology Overview available on the AAOS website These Technology Overview Tables were prepared using systematic review methodology, and summarize the findings of studies published as of April 1, on locking plates for extremity fractures. As a summary, this document does not make recommendations for or against the use of locking plates for extremity fractures. It should not be construed as an official position of the American Academy of Orthopaedic Surgeons. Readers are encouraged to consider the information presented in this document and reach their own conclusions about locking plates for extremity fractures. The American Academy of Orthopaedic Surgeons has developed and is providing the Technology Overview Tables as an educational tool. Patient care and treatment should always be based on a clinician s independent medical judgment given the individual patient s clinical circumstances.
2 Table 1. Patient Eollment Criteria for Included Studies Author Application Fracture Age Medical History Koshimune et al 16 Hahnloser et al Egol et al 5 Handschin et al 13 Hepp et al 14 Laflamme et al 19 Owsley et al 22 Sharafeldin et al 29 Gardner et al 10 Moonot et al 21 Koukakis et al Fankhauser et al 7 Distal Radius failed closed reduction, subchondral space for screws or pins Distal Radius >20 dorsal angulation, loss of radial length >10 mm Proximal Humerus adult Proximal Humerus displaced 2,3, or 4 part (Neer) fracture, no head split fracture no multiple injuries, able to perform post-op physiotherapy Proximal Humerus displaced fracture, 1.0 cm displacement or 45 angulation Proximal Humerus Proximal Humerus displaced (>1cm or >45 ) 2 part surgical neck or 3-part severely impacted (>160 ) valgus fracture skeletal maturity > 18 years fit for anesthesia, previous normal shoulder function Proximal Humerus Proximal Humerus Acute traumatic fracture Proximal Humerus displaced 3 or 4 part fracture Proximal Humerus closed 2,3,or 4 part (Neer) fracture, < 3 weeks old, Proximal Humerus nonpathologic, displaced, and unstable Schutz et al 28 Distal Femur any degree and severity skeletal maturity Wong et al 33 Fankhauser et al 8 Kregor et al 18 Markmiller et al 20 Ricci et al 23 Syed et al 32 Distal Femur no compound fracture > 18 years > 18 years > 60 years failed conservative treatment (unsatisfactory position), no primary or metastatic tumors no hemiparesis, no previous surgery on affected shoulder fit for surgery Distal Femur Distal Femur Supracondylar or intercondylar fracture, no periprosthetic, pathologic, growth plate, or medial femoral condyle fracture no nonunion of previous fracture Distal Femur Types 33 A 1-3 and C 1-3 Distal Femur Distal Femur acute, nonpathologic fracture (including displaced intra-articular and open fractures) any severity of fracture with or without intra-articular extension or bone loss, or open fracture. No severely articulated, comminuted fracture not amenable to reconstruction skeletal maturity skeletal maturity polytrauma = not reported The Schutz, et al study is a subgroup analysis of the Schutz, et al 2001 study.
3 Table 1. Patient Eollment Criteria for Included Studies (continued) Author Application Fracture Age Medical History Schutz et al Distal Femur All degrees and severity skeletal maturity Erhardt et al 6 Buttaro et al 3 Fulkerson et al 9 Ricci et al Jiang et al 15 Gosling et al 11 Stannard et al 31 Boldin et al Cole et al 4 Ricci et al 25 Schutz et al Stannard et al Bahari et al 1 Periprosthetic Femur Periprosthetic Femur Periprosthetic Femur Periprosthetic Femur Tibial Plateau Vancouver type B-1 Fracture pattern that can be adequately reduced (closed), adequate bone for fixation, well fixed implant (no loosening) supracondylar fracture above a well fixed, non stemmed, TKA (Type 33A) acute fracture. No pathologic, severe open (IIIB or IIIC), or concomitant ipsilateral femur fracture ability to walk without assistance prior to surgery, no patients requiring ICU or departmental transfer Tibial Plateau Type C Tibial Plateau High energy, acute bicondylar (Schatzker V) or meta/diaphyseal (Schatzker VI) fracture. No medially based (Schatzker IV) high energy fracture No tibial infections Proximal Tibia No AO type 41B fractures adult Proximal Tibia diaphyseal-metaphyseal dissociation with or without articular involvement Proximal Tibia comminuted metaphyseal fracture adult Proximal Tibia shaft and intra-articular fracture of any severity skeletal maturity Proximal Tibia any fracture, malunion, or nonunion adult unable or unwilling to follow-up Distal Tibia tibia or pilon fracture = not reported The Schutz, et al study is a subgroup analysis of the Schutz, et al 2001 study.
4 Table 2. Patient Oriented Outcomes from Comparative Studies - Distal Radius Outcome Measure Duration Application Mean (dispersion) % of patients Gartland and Werley Excellent Final Follow-up Distal Radius (LP) n/a 36% 22 Gartland and Werley Excellent Final Follow-up Distal Radius (NLP) n/a 32% 31 Gartland and Werley Good Final Follow-up Distal Radius (LP) n/a 59% 22 Gartland and Werley Good Final Follow-up Distal Radius (NLP) n/a 65% 31 Gartland and Werley Fair Final Follow-up Distal Radius (LP) n/a 5% 22 Gartland and Werley Fair Final Follow-up Distal Radius (NLP) n/a 3% 31 Gartland and Werley Poor Final Follow-up Distal Radius (LP) n/a 0% 22 Gartland and Werley Poor Final Follow-up Distal Radius (NLP) n/a 0% 31 Pain Absent (VAS = 0) 6 months Distal Radius (LP) n/a 33% 21 Pain Absent (VAS = 0) 6 months Distal Radius (NLP) n/a 44% 24 Pain Mild (VAS = 0-3) 6 months Distal Radius (LP) n/a 57% 21 Pain Mild (VAS = 0-3) 6 months Distal Radius (NLP) n/a 44% 24 Pain Moderate (VAS = 4-7) 6 months Distal Radius (LP) n/a 5% 21 Pain Moderate (VAS = 4-7) 6 months Distal Radius (NLP) n/a 12% 24 Pain Severe (VAS = 8-10) 6 months Distal Radius (LP) n/a 5% 21 Pain Severe (VAS = 8-10) 6 months Distal Radius (NLP) n/a 0% 24 Global Assessment Excellent 6 months Distal Radius (LP) n/a 29% 21 Global Assessment Excellent 6 months Distal Radius (NLP) n/a 52% 24 Global Assessment Good 6 months Distal Radius (LP) n/a 37% 21 Global Assessment Good 6 months Distal Radius (NLP) n/a 32% 24 Global Assessment Fair 6 months Distal Radius (LP) n/a 29% 21 Global Assessment Fair 6 months Distal Radius (NLP) n/a 16% 24 Global Assessment Poor 6 months Distal Radius (LP) n/a 5% 21 Global Assessment Poor 6 months Distal Radius (NLP) n/a 0% 24 Return to Previous Activities Distal Radius (LP) n/a 52% 21 Return to Previous Activities Distal Radius (NLP) n/a 50% 24 Grip Strength (% opposite hand) 6 months Distal Radius (LP) 85% (SD: ±24) n/a 21 Grip Strength (% opposite hand) 6 months Distal Radius (NLP) 95% (SD: ±9) n/a 24 Pinch Grip (% opposite hand) 6 months Distal Radius (LP) 89% (SD: ±23) n/a 21 Pinch Grip (% opposite hand) 6 months Distal Radius (NLP) 96% (SD: ±8) n/a 24 LP = Locking Plates; NLP = Non-Locking Plates; = not reported; n/a = not applicable; SD = standard deviation; SE = standard error; NS = not significant N p-value Author Koshimune et al 16 II Koshimune et al 16 II Koshimune et al 16 II Koshimune et al 16 II Hahnloser et al II Hahnloser et al II Hahnloser et al II Hahnloser et al II Hahnloser et al II Hahnloser et al II Hahnloser et al II Hahnloser et al II Hahnloser et al II Hahnloser et al II Hahnloser et al II
5 Table 3. Patient Oriented Outcomes from Comparative Studies - Proximal Humerus Outcome Measure Duration Application Mean (dispersion) % of patients Constant-Murley Score (all patients) Final Follow-up Proximal Humerus (LP) 59 (SE: ±11) n/a 31 Constant-Murley Score (all patients) Final Follow-up Proximal Humerus (NLP) 61 (SE: ±15) n/a 60 Constant-Murley Score (< 60 years old) Final Follow-up Proximal Humerus (LP) 62 (SE: ±8) n/a 31 Constant-Murley Score (< 60 years old) Final Follow-up Proximal Humerus (NLP) 70 (SE: ±14) n/a 60 Constant-Murley Score (> 60 years old) Final Follow-up Proximal Humerus (LP) 49 (SE: ±7) n/a 31 Constant-Murley Score (> 60 years old) Final Follow-up Proximal Humerus (NLP) 54 (SE: ±11) n/a 60 Constant-Murley Score (2-part fracture) Final Follow-up Proximal Humerus (LP) 64 (SE: ±8) n/a 8 Constant-Murley Score (2-part fracture) Final Follow-up Proximal Humerus (NLP) 67 (SE: ± 21) n/a 10 Constant-Murley Score (3-part fracture) Final Follow-up Proximal Humerus (LP) 60 (SE: ±7) n/a 13 Constant-Murley Score (3-part fracture) Final Follow-up Proximal Humerus (NLP) 62 (SE: ± 3) n/a 33 Constant-Murley Score (4-part fracture) Final Follow-up Proximal Humerus (LP) 57 (SE: ±8) n/a 10 Constant-Murley Score (4-part fracture) Final Follow-up Proximal Humerus (NLP) 57 (SE: ±12) n/a 17 Subjective Assessment Excellent Proximal Humerus (LP) n/a 20% 31 Subjective Assessment Excellent Proximal Humerus (NLP) n/a 32% 60 Subjective Assessment Good Proximal Humerus (LP) n/a 60% 31 Subjective Assessment Good Proximal Humerus (NLP) n/a 42% 60 Subjective Assessment Fair Proximal Humerus (LP) n/a 10% 31 Subjective Assessment Fair Proximal Humerus (NLP) n/a 20% 60 Subjective Assessment Poor Proximal Humerus (LP) n/a 10% 31 Subjective Assessment Poor Proximal Humerus (NLP) n/a 6% 60 Operative Time (minutes) n/a Proximal Humerus (LP) 153 (SE: ±62) n/a 31 Operative Time (minutes) n/a Proximal Humerus (NLP) 110 (SE: ±42) n/a 60 Hospitalized (days) n/a Proximal Humerus (LP) 8 (range: 3-9) n/a 31 Hospitalized (days) n/a Proximal Humerus (NLP) 12.6 (range: 5-26) n/a 60 LP = Locking Plates; NLP = Non-Locking Plates; = not reported; n/a = not applicable; SD = standard deviation; SE = standard error; NS = not significant N p-value Author NS Handschin et al 13 III NS Handschin et al 13 III NS Handschin et al 13 III NS Handschin et al 13 III NS Handschin et al 13 III NS Handschin et al 13 III Handschin et al 13 III Handschin et al 13 III Handschin et al 13 III Handschin et al 13 III NS Handschin et al 13 III NS Handschin et al 13 III
6 Table 4. Patient Oriented Outcomes from Comparative Studies - Tibial Plateau Outcome Measure Duration Application Mean (dispersion) % of patients HSS Score 12 months Tibial Plateau (LP) 81.8 (SD: ±4.7) n/a 41 HSS Score 12 months Tibial Plateau (NLP) 80.3 (SD: ±6.6) n/a 43 HSS Score 24 months Tibial Plateau (LP) 83.3 (SD: ±4.4) n/a 41 HSS Score 24 months Tibial Plateau (NLP) 83.1 (SD: ±6.3) n/a 43 Operative Time (minutes) n/a Tibial Plateau (LP) 347 (SD: ±65) n/a 41 Operative Time (minutes) n/a Tibial Plateau (NLP) 410 (SD: ±106) n/a 43 LP = Locking Plates; NLP = Non-Locking Plates; = not reported; n/a = not applicable; SD = standard deviation; SE = standard error; NS = not significant N p-value Author Jiang et al 15 II Jiang et al 15 II Jiang et al 15 II
7 Table 5. Patient Oriented Outcomes from Case Series Studies - Proximal Humerus Outcome Measure Duration N Author Mean (dispersion) % of patients Constant-Murley Score 1.5 months 40.2 (range: 19-62) n/a 28 Fankhauser et al 7 IV Constant-Murley Score 3 months 54.4 (range: 29-77) n/a 28 Fankhauser et al 7 IV Constant-Murley Score 3 months 53.5 (range: 23-93) n/a 83 Hepp et al 14 IV Constant-Murley Score 3-6 months 76.1 (range: ) n/a 18 Koukakis et al IV Constant-Murley Score 6 months 61.2 (range: 35-79) n/a 28 Fankhauser et al 7 IV Constant-Murley Score 6 months 70.4 (range: ) n/a 83 Hepp et al 14 IV Constant-Murley Score 11 months 66.5 (range: 30-90) n/a 32 Moonot et al 21 IV Constant-Murley Score 12 months 74.6 (range: 37-96) n/a 28 Fankhauser et al 7 IV Constant-Murley Score 12 months 77.2 (range: ) n/a 83 Hepp et al 14 IV Constant-Murley Score 12 months 79 () n/a 34 Laflamme et al 19 IV Constant-Murley Score Final Follow-up 82 (SD: ±16) n/a 34 Laflamme et al 19 IV Constant-Murley Score 50.5 (SD: ±17.8) n/a 27 Sharafeldin et al 29 IV Constant-Murley Score Activity Final Follow-up 15.1 (SD: ±3.8) n/a 34 Laflamme et al 19 IV Constant-Murley Score ADL 1.5 months 3.6 (range: 0-6) n/a 28 Fankhauser et al 7 IV Constant-Murley Score ADL 3 months 4.9 (range: 0-8) n/a 28 Fankhauser et al 7 IV Constant-Murley Score ADL 6 months 5.4 (range: 3-8) n/a 28 Fankhauser et al 7 IV Constant-Murley Score ADL 12 months 7.9 (range: 3-10) n/a 28 Fankhauser et al 7 IV Constant-Murley Score Mobility Final Follow-up 30.1 (SD: ±7.9) n/a 34 Laflamme et al 19 IV Constant-Murley Score Pain 1.5 months 9.8 (range: 5-15) n/a 28 Fankhauser et al 7 IV Constant-Murley Score Pain 3 months 10.9 (range: 5-15) n/a 28 Fankhauser et al 7 IV Constant-Murley Score Pain 6 months 12.0 (range: 7-15) n/a 28 Fankhauser et al 7 IV Constant-Murley Score Pain 12 months 13.9 (range: 8-15) n/a 28 Fankhauser et al 7 IV Constant-Murley Score Power 1.5 months 9.9 (range: 5-15) n/a 28 Fankhauser et al 7 IV Constant-Murley Score Power 3 months 13.0 (range: 7-19) n/a 28 Fankhauser et al 7 IV Constant-Murley Score Power 6 months 15.4 (range: 9-19) n/a 28 Fankhauser et al 7 IV Constant-Murley Score Power 12 months 17.6 (range: 9-23) n/a 28 Fankhauser et al 7 IV Constant-Murley Score Power Final Follow-up 21.8 (SD: ±4.9) n/a 34 Laflamme et al 19 IV Constant-Murley Score Excellent 11 months n/a 47% 32 Moonot et al 21 IV Constant-Murley Score Satisfactory 11 months n/a 37% 32 Moonot et al 21 IV Constant-Murley Score Poor 11 months n/a 16% 32 Moonot et al 21 IV = not reported; n/a = not applicable; SD = standard deviation; SE = standard error
8 Table 5. Patient Oriented Outcomes from Case Series Studies - Proximal Humerus (continued) Outcome Measure Duration N Author Mean (dispersion) % of patients Blood Loss (cc) n/a 113 (range: ) n/a 34 Laflamme et al 19 IV Blood Loss (g/dl) n/a 2.8 n/a 20 Koukakis et al IV DASH score 51.8 (SD: ±17.6) n/a 27 Sharafeldin et al 29 IV DASH Score 12 months 21 () n/a 34 Laflamme et al 19 IV DASH Score Final Follow-up 26.2 (SD: ±26.5) n/a 34 Laflamme et al 19 IV Quick DASH 12 months 15 () n/a 53 Owsley et al 22 IV Quick DASH-S 12 months 7 () n/a 53 Owsley et al 22 IV Quick DASH-W 12 months 11 () n/a 53 Owsley et al 22 IV Hospitalized (days) 5 (range: 0-174) n/a 27 Sharafeldin et al 29 IV Operative Time (minutes) n/a 75 (range: ) n/a 20 Koukakis et al IV Operative Time (minutes) n/a 53 (range: ) n/a 34 Laflamme et al 19 IV SF-36 Function 88.0 (SD: ±18.5) n/a 27 Sharafeldin et al 29 IV SF-36 Physical 68.7 (SD: ±28.1) n/a 27 Sharafeldin et al 29 IV SMFA 12 months 47 (range: 34-94) n/a 53 Owsley et al 22 IV SMFA-B 12 months 14 () n/a 53 Owsley et al 22 IV SMFA-F 12 months 10 () n/a 53 Owsley et al 22 IV = not reported; n/a = not applicable; SD = standard deviation; SE = standard error
9 Table 6. Patient Oriented Outcomes from Case Series Studies - Distal Femur Outcome Measure Duration N Author Mean (dispersion) % of patients Blood Loss (cm 3 ) n/a 373 (range: ) n/a 99 Kregor et al 18 IV Hospitalized (days) n/a 22 (range: 5-61) n/a 27 Fankhauser et al 8 IV HSS Excellent Final Follow-up n/a 24% 25 Syed et al 32 IV HSS Fair Final Follow-up n/a 16% 25 Syed et al 32 IV HSS Good Final Follow-up n/a 40% 25 Syed et al 32 IV HSS Poor Final Follow-up n/a 20% 25 Syed et al 32 IV HSS Score Final Follow-up 71.7 () n/a 25 Syed et al 32 IV Knee Society Score 20 months 131 (range: ) n/a 27 Fankhauser et al 8 IV Lysholm Score 3 months 48 () n/a 16 Markmiller et al 20 IV Lysholm Score 12 months 81 () n/a 16 Markmiller et al 20 IV Lysholm Score 20 months 71 (range: ) n/a 27 Fankhauser et al 8 IV Lysholm Score Excellent (80-100) 12 months n/a 87.5% 16 Markmiller et al 20 IV Lysholm Score Fair (70-79) 12 months n/a 12.5% 16 Markmiller et al 20 IV Lysholm Score Poor (<70) 12 months n/a 0% 16 Markmiller et al 20 IV Operative Time (minutes) n/a 183 (range: ) n/a 99 Kregor et al 18 IV Operative Time (minutes) n/a 155 () n/a 16 Markmiller et al 20 IV Operative Time (minutes) n/a 96 (range: ) n/a 96 Schutz et al IV Oxford Knee Score 23 months 46 (range: 22-60) n/a 16 Wong et al 33 IV Pain Free 10 weeks n/a 100% 18 Ricci et al 23 IV Pain Absent 12 months n/a 62.5% 16 Markmiller et al 20 IV Pain Absent 20 months n/a 22% 27 Fankhauser et al 8 IV Pain Absent 23 months n/a 56% 16 Wong et al 33 IV Pain At Rest 23 months n/a 12.5% 16 Wong et al 33 IV Pain Slight 20 months n/a 37% 27 Fankhauser et al 8 IV Pain Occasional Moderate 20 months n/a 33% 27 Fankhauser et al 8 IV Pain Constant Moderate 20 months n/a 8% 27 Fankhauser et al 8 IV Pain On Loading 12 months n/a 37.5% 16 Markmiller et al 20 IV Pain Weight Bearing 23 months n/a 19% 16 Wong et al 33 IV Pain Requiring Oral Analgesic 23 months n/a 12.5% 16 Wong et al 33 IV = not reported; n/a = not applicable; SD = standard deviation; SE = standard error The Schutz, et al study is a subgroup analysis of the Schutz, et al 2001 study.
10 Table 6. Patient Oriented Outcomes from Case Series Studies - Distal Femur (continued) Outcome Measure Duration N Author Mean (dispersion) % of patients SF-36 Mental 30 months 54.8 (SD: ±2.9) n/a 18 Ricci et al 23 IV SF-36 Physical 30 months 53.6 (SD: ±4.7) n/a 18 Ricci et al 23 IV Weight Bearing - Full (weeks) n/a (range: 6-18) n/a 27 Fankhauser et al 8 IV Weight Bearing - Full (weeks) n/a 12 (range: 5-24) n/a 99 Kregor et al 18 IV Weight Bearing - Full 12 months n/a 92% 52 Schutz et al 28 IV Weight Bearing - Partial 12 months n/a 6% 52 Schutz et al 28 IV Weight Bearing - None 12 months n/a 2% 52 Schutz et al 28 IV = not reported; n/a = not applicable; SD = standard deviation; SE = standard error The Schutz, et al study is a subgroup analysis of the Schutz, et al 2001 study. Table 7. Patient Oriented Outcomes from Case Series Studies - Periprosthetic Femur Outcome Measure Duration N Author Mean (dispersion) % of patients Blood Loss < 50 ml n/a n/a 100% 24 Fulkerson et al 9 IV d Aubigne and Postel Score Gait 5.0 () n/a 14 Buttaro et al 3 IV d Aubigne and Postel Score Mobility 5.4 () n/a 14 Buttaro et al 3 IV d Aubigne and Postel Score - Pain 5.8 () n/a 14 Buttaro et al 3 IV Hospitalized (days) n/a 14.5 () n/a 24 Erhardt et al 6 IV Operative Time (minutes) n/a 101 (range: ) n/a 14 Buttaro et al 3 IV Operative Time (minutes) n/a () n/a 24 Erhardt et al 6 IV Operative Time (minutes) n/a 90 (range: ) n/a 24 Fulkerson et al 9 IV Return to Previous Activities Final Follow-up n/a 91% 22 Erhardt et al 6 IV Return to Previous Ambulatory Status Final Follow-up n/a 55% 20 Ricci et al IV Subjective Contentment High Final Follow-up n/a 90% 21 Erhardt et al 6 IV Subjective Contentment Medium Final Follow-up n/a 5% 21 Erhardt et al 6 IV Subjective Contentment Low Final Follow-up n/a 5% 21 Erhardt et al 6 IV Time to Weight Bearing (weeks) n/a 13 (range: 8-18) n/a 22 Ricci et al IV = not reported; n/a = not applicable; SD = standard deviation; SE = standard error
11 Table 8. Patient Oriented Outcomes from Case Series Studies - Tibial Plateau Outcome Measure Duration N Author Mean (dispersion) % of patients Operative Time (minutes) n/a (range: ) n/a 62 Gosling et al 11 IV SF-36 Physical 6 months 29 n/a 33 Stannard et al 31 IV SF-36 Physical 12 months 40 (range: 24-60) n/a 33 Stannard et al 31 IV SF-36 Mental 6 months 51 () n/a 33 Stannard et al 31 IV SF-36 Mental 12 months 52 () = not reported; n/a = not applicable; SD = standard deviation; SE = standard error n/a 33 Stannard et al 31 IV Table 9. Patient Oriented Outcomes from Case Series Studies - Proximal Tibia Outcome Measure Duration N Author Mean (dispersion) % of patients HSS Score 3 years 79.3 () n/a 24 Boldin et al IV Knee Society Score 3 years 84.2 () n/a 24 Boldin et al IV Functional Score 3 years 85.6 () n/a 24 Boldin et al IV Full Weight Bearing (weeks) n/a 12.6 (range: 6-21) n/a 75 Cole et al 4 IV Operative Time (minutes) n/a 122 (range: ) n/a 20 Schutz et al IV = not reported; n/a = not applicable; SD = standard deviation; SE = standard error Table 10. Patient Oriented Outcomes from Case Series Studies - Distal Tibia Outcome Measure Duration N Author Mean (dispersion) % of patients AOFAS Score 19 months 90 () n/a 42 Bahari et al 1 IV SF-36 Score 19 months 85 () n/a 42 Bahari et al 1 IV = not reported; n/a = not applicable; SD = standard deviation; SE = standard error
12 Table 11. Adverse Events and Complications - Proximal Humerus and Distal Radius LP = Locking Plates patients NLP = Non-Locking Plates patients = Not Reported * author(s) report overall complications ** plate or screw failure/break *** author(s) did not specify deep/superficial **** patient underwent another surgical procedure due to implant Author Application N Koshimune et al 16 II Hahnloser et al II Distal Radius (LP) Distal Radius (NLP) Distal Radius (LP) Distal Radius (NLP) Complications (any)* Avascular Necrosis Extensor Tendon or Nerve Injury Failure of Hardware** Hemiarthroplasty Heterotropic Ossification Implant Removal Implant Replaced Infection, any*** Infection, Deep Infection, Superficial Nerve Palsy or Parasthesia Redislocation Reoperation**** Screw Pullout Secondary Palmar Dislocation Subacromial Impingement 22 0% 31 0% 21 14% 0% 19% 0% 0% 5% 10% 24 0% 0% 4% 0% 0% 0% 0% Egol et al 5 IV Proximal Humerus 51 24% 4% 4% 2% 2% 16% 2% Handschin et al 13 III Proximal Humerus (LP) Proximal Humerus (NLP) 31 16% 6% 0% 6% 3% 10% 6% 60 15% 3% 2% 7% 2% 12% 3% Hepp et al 14 IV Proximal Humerus 83 5% 1% 1% 0% 11% 2% Laflamme et al 19 IV Proximal Humerus 34 0% 0% 3% 0% 6% Owsley et al 22 IV Proximal Humerus 53 36% 4% 0% 4% 8% 13% 2% Sharafeldin et al 29 IV Proximal Humerus 27 4% Gardner et al 10 IV Proximal Humerus 35 3% 11% Moonot et al 21 IV Proximal Humerus 32 3% 3% 3% 3% 9% 9% Koukakis et al IV Proximal Humerus 20 5% 5% 5% 0% Fankhauser et al 7 IV Proximal Humerus 28 7% 4% 4% 4% 7% 7% 14% Sudeck Syndrome Tenosynovitis
13 Table 12. Adverse Events and Complications - Distal Femur and Periprosthetic Femur LP = Locking Plates patients NLP = Non-Locking Plates patients = Not Reported * author(s) report overall complications ** plate or screw failure/break *** author(s) did not specify deep/superficial **** patient underwent another surgical procedure due to implant Author Application N Complications (any)* Compartment Syndrome Deep Vein Thrombosis Schutz et al 28 IV Distal Femur 52 Wong et al 33 IV Distal Femur 16 13% Fankhauser et al 8 IV Distal Femur 27 26% 26% 22% 11% Kregor et al 18 IV Distal Femur 99 9% 1% 3% 3% 5% Markmiller et al 20 IV Distal Femur 16 0% 0% Ricci et al 23 IV Distal Femur 18 Syed et al 32 IV Distal Femur 25 1% 4% 4% 8% 8% 12% Schutz et al IV Distal Femur 96 1% 2% 4% 1% 22% 1% Erhardt et al 6 IV Buttaro et al 3 IV Fulkerson et al 9 IV Ricci et al IV Periprosthetic Femur Periprosthetic Femur Periprosthetic Femur Periprosthetic Femur The Schutz, et al study is a subgroup analysis of the Schutz, et al 2001 study. Failure of Hardware** Iliotibial Tract Pain Implant Removal Infection, any*** Infection, Deep Infection, Superficial Infection, MRSA Instability Pulmonary Embolism Reoperation**** Revised to Amputation 21 14% 5% 14% 14 21% 29% 24 29% 4% 25% 22 0% 9% Screw Pullout
14 Table 13. Adverse Events and Complications - Tibial Plateau, Proximal Tibia, Distal Tibia LP = Locking Plates patients NLP = Non-Locking Plates patients = Not Reported * author(s) report overall complications ** plate or screw failure/break *** author(s) did not specify deep/superficial **** patient underwent another surgical procedure due to implant Author Application Jiang et al 15 II Tibial Plateau (LP) Tibial Plateau (NLP) N Complications (any)* Compartment Syndrome Deep Vein Thrombosis Failure of Hardware** Fasciotomy Implant Pain Implant Removal Infection, any*** Infection, Deep Infection, Superficial Irritation from Hardware Nerve Palsy Pulmonary Embolism Reoperation**** Revised to TKA Revised to Amputation Tenderness or Impingement 41 63% 2% 0% 17% 17% 7% 10% 12% 24% 43 49% 5% 2% 9% 12% 5% 7% 0% 22% Gosling et al 11 IV Tibial Plateau 62 2% 2% 6% Stannard et al 31 IV Tibial Plateau 33 18% 30% 6% 6% 3% Boldin et al IV Proximal Tibia 24 8% 0% 8% 4% Cole et al 4 IV Proximal Tibia 75 3% 13% 3% 5% 3% 13% 4% Ricci et al 25 IV Proximal Tibia 38 5% 11% 5% 5% 0% 3% Schutz et al IV Proximal Tibia 20 5% 15% Stannard et al IV Proximal Tibia 32 6% Bahari et al 1 IV Distal Tibia 42 2% 7% 2% 5% 12% Wound Hematoma/Seroma
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16 (13) Handschin AE, Cardell M, Contaldo C, Trentz O, Wanner GA. Functional results of angularstable plate fixation in displaced proximal humeral fractures. Injury March;39(3): (14) Hepp P, Theopold J, Voigt C, Engel T, Josten C, Lill H. The surgical approach for locking plate osteosynthesis of displaced proximal humeral fractures influences the functional outcome. J Shoulder Elbow Surg January;17(1):21-8. (15) Jiang R, Luo CF, Wang MC, Yang TY, Zeng BF. A comparative study of Less Invasive Stabilization System (LISS) fixation and two-incision double plating for the treatment of bicondylar tibial plateau fractures. Knee March;15(2): (16) Koshimune M, Kamano M, Takamatsu K, Ohashi H. A randomized comparison of locking and non-locking palmar plating for unstable Colles' fractures in the elderly. J Hand Surg [Br] October;30(5): (17) Koukakis A, Apostolou CD, Taneja T, Korres DS, Amini A. Fixation of proximal humerus fractures using the PHILOS plate: early experience. Clin Orthop Relat Res 2006 January;442: (18) Kregor PJ, Stannard JA, Zlowodzki M, Cole PA. Treatment of distal femur fractures using the less invasive stabilization system: surgical experience and early clinical results in 103 fractures. J Orthop Trauma September;18(8): (19) Laflamme GY, Rouleau DM, Berry GK, Beaumont PH, Reindl R, Harvey EJ. Percutaneous Humeral Plating of Fractures of the Proximal Humerus: of a Prospective Multicenter Clinical Trial. J Orthop Trauma March;22(3): (20) Markmiller M, Koad G, Sudkamp N. Femur-LISS and distal femoral nail for fixation of distal femoral fractures: are there differences in outcome and complications? Clin Orthop Relat Res September;(426): (21) Moonot P, Ashwood N, Hamlet M. Early results for treatment of three- and four-part fractures of the proximal humerus using the PHILOS plate system. J Bone Joint Surg Br September;89(9): (22) Owsley KC, Gorczyca JT. Displacement/screw cutout after open reduction and locked plate fixation of humeral fractures. J Bone Joint Surg Am February;90(2): (23) Ricci AR, Yue JJ, Taffet R, Catalano JB, DeFalco RA, Wilkens KJ. Less Invasive Stabilization System for treatment of distal femur fractures. Am J Orthop May;33(5): (24) Ricci WM, Loftus T, Cox C, Borrelli J. Locked plates combined with minimally invasive insertion technique for the treatment of periprosthetic supracondylar femur fractures above a total knee arthroplasty. J Orthop Trauma 2006 March;20(3):190-6.
17 (25) Ricci WM, Rudzki JR, Borrelli J, Jr. Treatment of complex proximal tibia fractures with the less invasive skeletal stabilization system. J Orthop Trauma September;18(8): (26) Schutz M, Kaab MJ, Haas N. Stabilization of proximal tibial fractures with the LIS-System: early clinical experience in Berlin. Injury 2003 August;34 Suppl 1:A30-A35. (27) Schutz M, Muller M, Krettek C et al. Minimally invasive fracture stabilization of distal femoral fractures with the LISS: a prospective multicenter study. of a clinical study with special emphasis on difficult cases. Injury 2001 December;32 Suppl 3:SC48-SC54. (28) Schutz M, Muller M, Regazzoni P et al. Use of the less invasive stabilization system (LISS) in patients with distal femoral (AO33) fractures: a prospective multicenter study. Arch Orthop Trauma Surg March;125(2): (29) Sharafeldin KN, Quinlan JF, Corrigan J, Kelly IP. Functional follow-up of locking plate fixation of fractures of the proximal humerus. European Journal of Orthopaedic Surgery and Traumatology 18(2)()(pp 87-92), Date of Publication: Feb ;(2): (30) Stannard JP, Wilson TC, Volgas DA, Alonso JE. Fracture stabilization of proximal tibial fractures with the proximal tibial LISS: early experience in Birmingham, Alabama (USA). Injury 2003 August;34 Suppl 1:A36-A42. (31) Stannard JP, Wilson TC, Volgas DA, Alonso JE. The less invasive stabilization system in the treatment of complex fractures of the tibial plateau: short-term results. J Orthop Trauma September;18(8): (32) Syed AA, Agarwal M, Giannoudis PV, Matthews SJ, Smith RM. Distal femoral fractures: long-term outcome following stabilisation with the LISS. Injury June;35(6): (33) Wong MK, Leung F, Chow SP. Treatment of distal femoral fractures in the elderly using a less-invasive plating technique. Int Orthop April;29(2):
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